Crinetics Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
CRNX 11.12.2024
Drug:NDA-001 paltusotine
Diseases:acromegaly
Date of Upcoming Event:2024-11-21
Name of Upcoming Event:North American Neuroendocrine Tumor Society (NANETS) Annual Meeting
About Gravity Analytica
Recent News
- 01.15.2025 - Crinetics to Participate in the 43rd Annual J.P. Morgan Healthcare Conference
- 01.10.2025 - Crinetics Announces January 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
- 01.10.2025 - Crinetics Pharmaceuticals Announces January 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Recent Filings
Submission of New Drug Application for Paltusotine for the Treatment of Acromegaly
Completed Upsized Public Offering of
Debut of First Drug Candidate from a Novel Nonpeptide Drug Conjugate Platform at
Total of Four New Drug Candidates in IND-Enabling Preclinical Studies
Management Hosting Conference Call at
“As we approach the end of 2024, it has been yet another remarkable year for Crinetics as we continued to consistently achieve key milestones to advance and expand our pipeline and strengthen the company’s position,” said
Third Quarter 2024 and Recent Highlights:
- Submitted New Drug Application (NDA) for paltusotine for the treatment of acromegaly.In September, Crineticssubmitted an NDA to the
U.S. Food and Drug Administration (FDA) for its investigational drug, paltusotine, the first once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment of and long-term maintenance therapy for acromegaly. Crinetics anticipates receiving notification from the FDA on the status of the NDA submission inDecember 2024 . - Strengthened balance sheet with
$575 million public offering.In October, Crinetics completed anupsized public offering of common stockfor gross proceeds of$575 million . - Selected development candidate in TSH antagonist program.Crinetics has identified an oral thyroid stimulating hormone (TSH) receptor antagonist for the potential treatment of Graves’ disease and thyroid eye disease. First-in-human-enabling studies have commenced and an Investigational New Drug (IND) filing is expected in 2025.
- Data from CRN09682, the first drug candidate from novel Nonpeptide Drug Conjugate (NDC) platform, to be presented at the
North American Neuroendocrine Tumor Society (NANETS)Annual MeetinginNovember 2024 .First-in-human-enabling activities are nearing completion and IND filing is expected in early 2025. - Total of four development candidates currently in IND-enabling studies to support transition to clinical development in 2025.
Key Upcoming Milestones:
- Additional data from the Phase 2 study of its investigational drug atumelnant* in CAH is anticipated by early 2025.
- Crinetics expects to finalize a Phase 3 protocol and initiate site startup activities for its investigational drug paltusotine in carcinoid syndrome by the end of 2024.
Third Quarter 2024 Financial Results:
- Research and development expenses were
$61.9 million for the three months endedSeptember 30, 2024 , compared to$43.8 million for the same period in 2023. The increase was primarily attributable to higher personnel costs, outside services costs, and manufacturing activities costs, all of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio. - General and administrative expenses were
$25.9 million for the three monthsSeptember 30, 2024 , compared to$15.5 million for the same period in 2023. The increase was primarily driven by higher personnel costs and outside services costs. - Net loss for the three months ended
September 30, 2024 , was$76.8 million , compared to a net loss of$57.5 million for the same period in 2023. - There were no revenues during the three months ended
September 30, 2024 , compared to revenues of$0.3 million for the same period in 2023. Third quarter 2023 revenues were derived from the paltusotine licensing arrangement with our Japanese partner,Sanwa Kagaku Kenkyusho (SKK). - Cash, cash equivalents, and investment securities totaled
$862.7 million as ofSeptember 30, 2024 , compared to$558.6 million as ofDecember 31, 2023 . OnOctober 10, 2024 , the Company completed an upsized underwritten public offering of common stock for gross proceeds of$575 million , strengthening its financial position with approximately$1.4 billion in cash, cash equivalents and investment securities. Based on current projections, Crinetics expects that its cash, cash equivalents and investment securities will be sufficient to fund its current operating plan into 2029.
Conference Call and Webcast DetailsManagement will hold a live conference call and webcast today,
*Proposed international nonproprietary name under review.
About
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the plans and timelines for FDA response and the commercial launch of paltusotine if the NDA submission is approved; the expected timing of initiation of a Phase 3 program of paltusotine for carcinoid syndrome and FDA consultation; the expected timing of additional data and topline results from studies of atumelnant in CAH and Cushing’s syndrome; the expected timing of announcing preclinical data for a candidate on the NDC platform; the potential and expected timing for IND-enabling studies in four different development candidates to transition to clinical development; the expected timing of additional research pipeline updates; and the expected timing through which our cash, cash equivalents, and investment securities will fund our operating plans. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments in
| Three months ended | Nine months ended | |||||||||||||||
| STATEMENTS OF OPERATIONS DATA: | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues | $ | — | $ | 346 | $ | 1,039 | $ | 4,013 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 61,905 | 43,839 | 173,590 | 122,947 | ||||||||||||
| General and administrative | 25,892 | 15,484 | 71,558 | 41,016 | ||||||||||||
| Total operating expenses | 87,797 | 59,323 | 245,148 | 163,963 | ||||||||||||
| Loss from operations | (87,797 | ) | (58,977 | ) | (244,109 | ) | (159,950 | ) | ||||||||
| Total other income, net | 10,969 | 2,516 | 26,766 | 6,515 | ||||||||||||
| Loss before equity method investment | (76,828 | ) | (56,461 | ) | (217,343 | ) | (153,435 | ) | ||||||||
| Loss on equity method investment | — | (997 | ) | (470 | ) | (997 | ) | |||||||||
| Net loss | $ | (76,828 | ) | $ | (57,458 | ) | $ | (217,813 | ) | $ | (154,432 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.96 | ) | $ | (1.01 | ) | $ | (2.82 | ) | $ | (2.81 | ) | ||||
| Weighted-average shares - basic and diluted | 80,091 | 56,808 | 77,173 | 55,003 | ||||||||||||
| BALANCE SHEET DATA: | ||||||||
| Cash, cash equivalents and investments | $ | 862,668 | $ | 558,555 | ||||
| Working capital | $ | 824,025 | $ | 530,211 | ||||
| Total assets | $ | 937,374 | $ | 635,353 | ||||
| Total liabilities | $ | 104,394 | $ | 96,247 | ||||
| Accumulated deficit | $ | (871,515 | ) | $ | (653,702 | ) | ||
| Total stockholders’ equity | $ | 832,980 | $ | 539,106 | ||||
Investors:
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Source: Crinetics Pharmaceuticals, Inc.